Development and design

Elos Medtech specifies requirements and areas of usage as early as the conceptual and design phases. We contribute everything from 3D manufacturing drawings to advanced FEA calculations. Our development engineers work closely with customers to shorten the time from concept and production to market launch.

Elos Medtech has extensive experience of product development, design of dental implants, orthopedic products and medical instruments. We have kept abreast of developments since the 1960s (first hip pins and later, starting in the 1980s, also dental products). In the Dental business area, we have cooperated with, for example, Professor Per-Ingvar Brånemark on product development and experiments.

Thanks to close proximity to production and our own prototype manufacturing, our development engineers have extensive experience of various production steps. This means that “Design for manufacturing” is our great strength. Elos Medtech has many years of experience of various types of materials, primarily various kinds of specialist materials such as titanium, but also more modern plastic materials such as Peek.

Design occurs in 3D environments and durability calculations are conducted using FEA calculations. All support documents and tests are developed so they can be used as documentation in technical files, etc. Packaging can also be designed during the development stage.
 

Regulatory requirements

8Regulatory requirements
Elos Medtech’s quality is well documented and we are certified in accordance with the standards required in the area. We also have the right to CE label our manufactured products up to class II b. We now have an independent quality department and we are certified in accordance with ISO 14001, ISO 13485 and EEC/MDD 93/42.

Certificates:
• ISO 14001:2004
• ISO 13485:2003
• EEC/MDD 93/42

In the US, we are registered with the FDA (Food and Drug Administration) and operate in accordance with American standards such as QSR and GMP.
 

Prototypes and test series

Prototypes
We are able to quickly develop prototypes in our experimental workshop. These prototypes are based either on results from the development and design phase or from our customers’ own drawings. Development work continues once the prototype fulfills the desired requirements.

Our design engineers’ proximity to the experimental workshop adds flexibility and facilitates time-efficient projects. Prototypes for clinical and mechanical studies are developed in the experimental workshop. Both static and dynamic durability testing is conducted in our own test laboratory.

Preliminary series
Preliminary series are used to verify product quality and manufacturing processes, and can be based either on our own drawings or those of our customers. Preliminary series are produced using the same machinery that will be used for large-scale production.
A preliminary series enables the testing of production and products in a full-scale environment – but with small production runs. In conjunction with our test series, all of our current processes are qualified and validated.

Packaging is also tested to ensure that it corresponds to the stated requirements for transportation durability, tightness, etc.
 

Production

State-of-the-art manufacturing technology combined with our experience and knowledge results in high-quality manufacturing, where we fulfill the requirements posed on us and our products.

With a modern machine park, which is continually upgraded, there is equipment for both short series as well as comprehensive serial production. All of the production at Elos Medtech is hallmarked by the highest quality combined with flexibility. Advanced measurement equipment is used both in serial production and during final inspections. Production quality is assured across many steps through statistical process management or AQL sampling.

Elos Medtech’s production is continuously improved, with a focus on quality, cost-effectiveness and delivery reliability.
 

Clean room

Functional inspections and packaging occur in our clean rooms. We also sterilize packages of our products in order to maximize efficiency for our customers’ logistics.

Our clean rooms fulfill ISO Class 7 and ISO Class 5 for LAF benches. This is where assembly of components and automated blister and bagging of products takes place, even for direct deliveries to customers.

Labeling and marking provides full traceability for all products.
 

Logistics

Our logistics offerings include several solutions designed to meet the needs of our customers, thus facilitating and streamlining stock-keeping.

In order to minimize inventory costs and administration, Elos Medtech utilizes Vendor Managed Inventory (VMI) systems. This provides several advantages for our customers, including inventory maintenance, goods handling and ongoing delivery, as needed.